Oral product

ABSTRACT

An oral product includes a body that is wholly receivable in an oral cavity. The body includes a mouth-stable polymer matrix, cellulosic fibers embedded in the mouth-stable polymer matrix, and an additive dispersed in the mouth-stable polymer matrix. The oral product is adapted to release the additive from the body when the body is received within the oral cavity and exposed to saliva.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. application Ser. No.13/744,905, filed Jan. 18, 2013, which claims priority to U.S.Provisional Application Ser. No. 61/588,861 filed Jan. 20, 2012, whichis incorporated by reference in its entirety.

TECHNICAL FIELD

This document relates to oral products including mouth-stable polymersand one or more additives.

BACKGROUND

Oral products providing flavor and/or one or more active ingredients arewell known. One such oral product is chewing gum. Other oral productsinclude hard candies (e.g., mints). Softer gelatin-based oral productsare also known. Pharmaceutical and therapeutic products (e.g.,cough-suppressant lozenges) can also be provided in a solid form fororal consumption. The flavor release and/or active agent releasecharacteristics for an oral product are important for providing animproved consumer product.

SUMMARY

This specification describes an oral product that provides a satisfyingtactile and/or flavor experience. In particular embodiments, the oralproduct can provide an extended additive release time. The oral productincludes a body that is at least partially receivable in an oral cavityof a consumer. In some embodiments, the body includes a mouth-stablepolymer matrix, cellulosic fibers embedded in the stable polymer matrix,and one or more additives dispersed in the body such that it is releasedwhen the body is received within the oral cavity and exposed to saliva.

The oral product, according to certain embodiments, includes flavorants,sweeteners, vitamins, minerals, therapeutic agents, nutraceuticals,energizing agents, soothing agents, coloring agents, amino acids,chemesthetic agents, antioxidants, food grade emulsifiers, pH modifiers,botanicals, teeth whitening agents, and/or alkaloids (e.g., caffeine).Combinations of additives (e.g., sweeteners, flavorants, and caffeine)can be combined to provide a favorable tactile and flavor experience.

These and other embodiments can each optionally include one or more ofthe following features. In some embodiments, the oral product's bodyincludes at least 10 weight percent of the mouth-stable polymer. Themouth-stable polymer matrix can include polyurethane, silicon polymer,polyester, polyacrylate, polyethylene,poly(styrene-ethylene-butylene-styrene) (“SEBS”),poly(styrene-butadiene-styrene) (“SBS”),poly(styrene-isoprene-styrene)(“SIS”), and other similar thermoplasticelastomers, or any copolymer, mixture, or combination thereof. The oralproduct can also include a plasticizer dispersed in the mouth-stablepolymer matrix. For example, the plasticizer can be propylene glycol,glycerin, vegetable oil, triglycerides, or a combination thereof. Theoral product can also include a sweetener dispersed in the body. Thesweetener can be saccharine, sucralose, aspartame, acesulfame potassium,or a combination thereof.

The oral product, according to certain embodiments, can include anadditive selected from the group consisting of minerals, vitamins,dietary supplements, nutraceuticals, energizing agents, soothing agents,amino acids, chemesthetic agents, antioxidants, botanicals, teethwhitening agents, therapeutic agents, or a combination thereof. Theadditives can be absorbed into the cellulosic fibers and polymer matrix.

The oral product's body can have at least 10 weight percent cellulosicfibers. The cellulosic fibers can be derived from plant tissue. In someembodiments, the cellulosic fibers include cellulose. The cellulosicfibers can further include lignin and/or lipids. For example, thecellulosic fibers can be selected from the following: sugar beet fiber,wood pulp fiber, cotton fiber, bran fiber, citrus pulp fiber, grassfiber, willow fiber, poplar fiber, and combinations thereof. Thecellulosic fibers may also be chemically treated prior to use. Forexample, the cellulosic fibers can be CMC, HPMC, HPC, or other treatedcellulosic material.

The oral product can include flavorants. The flavorants can be naturalor artificial. Flavorants can be selected from the following: licorice,wintergreen, cherry and berry type flavorants, Drambuie, bourbon,scotch, whiskey, spearmint, peppermint, lavender, cinnamon, cardamon,Apium graveolens, clove, cascarilla, nutmeg, sandalwood, bergamot,geranium, honey essence, rose oil, vanilla, lemon oil, orange oil,Japanese mint, cassia, caraway, cognac, jasmine, chamomile, menthol,ylang-ylang, sage, fennel, pimenta, ginger, anise, coriander, coffee,mint oils from a species of the genus Mentha, cocoa, and combinationsthereof. Synthetic flavorants can also be used. The particularcombination of flavorants can be selected from the flavorants that aregenerally recognized as safe (“GRAS”) in a particular country, such asthe United States. Flavorants can also be included in the oral productas encapsulated flavorants.

The body of the oral product can have a variety of different shapes,some of which include disk, shield, rectangle, and square. According tocertain embodiments, the body can have a length or width of between 5 mmand 25 mm and a thickness of between 1 mm and 10 mm.

The oral product's body can be compressible and springy. In someembodiments, the body has a compressibility @ 250 N of less than 95%,less than 90%, less than 85%, or less than 80%. In some embodiments, thebody has a compressibility of @ 250 N of between 45% and 90%. The oralproduct's body can have a compressibility @ 425 N of less than 99%. Forexample, the body can have a compressibility @ 425 N of between 60% and98%. The body can also have a percentage of springiness of at least 20%,at least 30%, at least 40%, at least 50%, at least 60%, at least 70%, orat least 75%. For example, the body can have a percentage of springinessof between 75% and 90%.

The oral product can include a combination of soluble fibers andinsoluble cellulosic fibers. In some embodiments, a ratio of solublefiber to cellulosic fibers can be between 1:60 and 60:1. In someembodiments, the soluble fibers can include maltodextrin. In someembodiments, the soluble fibers comprise starch. The soluble fibers canbe derived from corn. In general, another aspect of the subject matterdescribed in this specification is methods of making and using the oralproduct. The methods of making the oral product can include the actionsof extruding a mouth-stable polymer having cellulosic fibers and/or oneor more additives dispersed therein.

The details of one or more embodiments of the subject matter describedin this specification are set forth in the accompanying drawings and thedescription below. Other features, aspects, and advantages of thesubject matter will become apparent from the description, the drawings,and the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a pair of oral products.

FIGS. 2A-2M illustrate various exemplary shapes of oral products.

FIGS. 3A and 3B illustrate oral products including surface features.

FIG. 4 illustrates a cross-section of a hypothetical oral product.

FIG. 5A illustrates a process diagram for making oral products accordingto some embodiments.

FIG. 5B illustrates an extruder configuration for making oral productsaccording to some embodiments.

FIG. 6A illustrates a process diagram for making oral products accordingto other embodiments.

FIG. 6B illustrates an extruder configuration for making oral productsaccording to certain embodiments.

FIG. 7 illustrates a rod of mouth-stable polymer exiting an extruderdie.

FIG. 8 illustrates how a cut piece of mouth-stable polymer includingfibers and/or additives can pillow.

DETAILED DESCRIPTION

The oral products described herein include a mouth-stable polymer matrixand one or more additives. The one or more additives can be dispersed inthe mouth-stable polymer matrix such that the one or more additives arereleased from the oral product when the oral product is received withinthe oral cavity and exposed to saliva. The oral products describedherein can provide a favorable additive release profile and tactileexperience.

Suitable mouth-stable polymers include thermoplastic elastomers such aspolyurethane. As used here, the term “mouth stable” means that thepolymer does not appreciably dissolve or disintegrate when exposed tosaliva within an oral cavity and at the normal human body temperature(e.g., about 98.6° F.) over a period of one hour. In addition tobiostable polymers, mouth-stable polymers can include biodegradablepolymers that breakdown over periods of days, weeks, months, and/oryears, but do not appreciably break down when held in an oral cavity andexposed to saliva for a period of one hour. In some embodiments, themouth-stable polymer is stable within an oral cavity and exposed tosaliva at the normal human body temperature for a period of at least 6hours, at least 12 hours, at least 24 hours, or at least 2 days.Accordingly, the oral products described herein can remain intact whenplaced within an oral cavity during a use period. After use, themouth-stable polymer matrix can be removed from the oral cavity anddiscarded.

The mouth-stable polymer can have shape stability. In some cases, theoral product 110 can be chewed without significant and instantaneouspermanent plastic deformation. As the oral product 100 is chewed, it canbecome more pliable and additional additives can become available forrelease into the oral cavity. Some embodiments of the oral product 110can be adapted to remain non-sticky during and after use. Afterprolonged use, certain embodiments of the oral product 110 will expandand become flatter. The oral product, however, can retain the essence ofits original shape.

One or more additives are included in the oral product and adapted to bereleased from the oral product when the oral product is placed in anoral cavity.

In addition to additives, sweeteners, and flavorants, the oral productcan also include fibers, fillers, plasticizers, and/or processing aids.Fibers can help to provide access to the additives, sweeteners, and/orflavorants. As will be discussed below, fibers can provide channels foradditives, sweeteners, and/or flavorants to leach out of themouth-stable polymer matrix. The fiber-polymer matrix can absorb one ormore additives and provide a pathway for one or more additives to bereleased from the oral product. The fiber-polymer matrix can be porous.In some embodiments, the fiber-polymer matrix can have a plurality ofpores having a pore diameter of between 40 microns and 60 microns and aplurality of pores having a pore diameter of between 1 micron and 10microns. During use, saliva can be absorbed into the fiber-polymermatrix to release the additives, sweeteners, and/or flavorants. Theabsorbed saliva can enter the pores and/or cause the fibers to expand,which can facilitate further release of additives, sweeteners, and/orflavorants. Mechanical action (e.g., chewing) of the oral product canfacilitate the release of the additives, sweeteners, and/or flavorants.

Fillers can also be included in the mouth-stable polymer matrix to alterthe texture or pliability of the oral product. The mouth-stable polymermatrix can also include plasticizers, which can increase the softness ofthe oral product. Processing aids can also be present in the oralproduct and be used to facilitate shaping processes.

Oral Product Shapes and Packaging

FIG. 1 depicts an example of an oral product 110. The oral product 110has a disk shape. For example, the oral product 110 can have a diameterof about 12 mm and a thickness of about 2.5 mm.

Referring now to FIGS. 2A-2M, the oral product 110 can be molded intoany desired shape. For example, referring to FIGS. 2A-2L, the oralproduct 110A-L can be formed in a shape that promotes improved oralpositioning in the oral cavity, improved packaging characteristics, orboth. In some circumstances, the oral product 110A-L can be configuredto be: (A) an elliptical-shaped oral product 110A; (B) an elongatedelliptical-shaped oral product 110B; (C) semi-circular oral product110C; (D) square or rectangular-shaped oral product 110D; (E)football-shaped oral product 110E; (F) elongated rectangular-shaped oralproduct 110F; (G) boomerang-shaped oral product 110G; (H) rounded-edgerectangular-shaped oral product 110H; (I) teardrop- or comma-shaped oralproduct 110I; (J) bowtie-shaped oral product 110J; (K) peanut-shapedoral product 110K; and (L) shield-shaped oral product. Alternatively,the oral product can have different thicknesses or dimensionality, suchthat a beveled article (e.g., a wedge) is produced (see, for example,product 110M depicted in FIG. 2M) or a hemi-spherical shape is produced.In some embodiments, the oral product has a shield shape.

In addition or in the alternative to flavorants being included withinthe mouth-stable polymer matrix, flavorants can be included on anexterior of the oral product 110. For example, referring to FIG. 3A, forexample, some embodiments of an oral product 120A can be equipped withflavor strips 116.

Referring to FIG. 3B, particular embodiments of the oral product 110 canbe embossed or stamped with a design (e.g., a logo, an image, or thelike). For example, the oral product 120B can be embossed or stampedwith any type of design 117 including, but not limited to, a trademark,a product name, or any type of image. The design 117 can be formeddirectly into the oral product, arranged along the exterior of theproduct 120B. The design 117 can also be embossed or stamped into thoseembodiments with a dissolvable film 116 applied thereto.

In some embodiments, the oral product 110 or products 110A-M can bewrapped or coated in an edible or dissolvable film, which may be opaque,substantially transparent or translucent. The dissolvable film canreadily dissipate when the oral product 110 is placed in an oral cavity.In some embodiments, the oral product 110 can be coated with amouth-stable material. Exemplary coating materials include Beeswax,gelatin, acetylated monoglyceride, starch (e.g., native potato starch,high amylose starch, hydroxypropylated potato starch), Zein, Shellac,ethyl cellulose, methylcellulose, hydroxypropyl methylcellulose,carboxymethyl cellulose, and combinations thereof. For example, acoating can include a combination of gelatin and methylcellulose. Insome embodiments, a coating material can include a plasticizer. In somecase, a coating can include a colorant, a flavorant, and/or a one ormore of the additives discussed above. For example, a coating caninclude caffeine to provide a user with an initial caffeine burst. Insome cases, the matrix of mouth-stable polymer 120 can have surfacesroughened to improve the adherence of a coating. In some cases, acoating can provide a glossy or semi-glossy appearance, a smoothsurface, and/or an appealing visual aesthetic (e.g., a nice color). Insome embodiments, the coating (e.g., a beeswax, Zein, acetylatedmonoglyceride, and/or hydroxypropylated potato starch coating) canprovide soft mouth feel. In some embodiments, the coating (e.g., amethylcellulose, hydroxypropyl methylcellulose, carboxymethyl cellulose,ethyl cellulose, and/or gelatin coating) can provide a hard outercoating.

One or more oral products 110 can be packaged in a variety ofconventional and non-conventional manners. For example, a plurality oforal products 110 can be packaged in a container having a lid. In otherembodiments, a plurality of oral products 110 can be stacked andpackaged in a paper, plastic, and/or aluminum foil tube. In someembodiments, such as for medications, the packaging can have achild-resistant lid.

The oral product 110 can also include additional elements. In someembodiments, a mouth-stable polymer matrix including one or moreadditives can be attached to a rod, tube, or stick. For example, thefiber-polymer matrix could be positioned on a stick to form a lollipoptype structure. In other embodiments, the coating could be formed on astick.

Oral Product Properties

The oral product 110 can provide a favorable tactile experience (e.g.,mouth feel). The oral product 110 can also retain its shape duringprocessing, shipping, handling, and optionally use. As noted above, theoral product 110 includes a mouth-stable polymer matrix that does notappreciably dissolve or disintegrate when placed in an oral cavity andexposed to saliva. In some embodiments, the oral product 110 can have anelasticity allowing a consumer to work the product within the mouth. Insome embodiments, the oral product 110 has at least some shape memoryand thus can return to shape after being squeezed between teeth in anoral cavity. Working of the oral product 110 within the oral cavity canaccelerate the release of the additives, sweeteners, and/or flavorantswithin the mouth-stable polymer matrix.

During use, the oral product 110 can absorb saliva into thepolymer-fiber matrix. The saliva can cause the polymer-fiber matrix toswell, which can further increase access to different sections of thepolymer-fiber matrix. Physical activity, such as chewing of the productin the mouth, can also accelerate the polymer-matrix swelling andtherefore the release of additives. As the product is chewed, saliva canaccess different sections of the polymer-fiber matrix. The mouth-stablepolymer can have shape stability. In some cases, the oral product 110can be chewed without significant and instantaneous permanent plasticdeformation (such as that experienced by a chewing gum when chewed). Asthe oral product 110 is chewed, it can become more pliable andadditional additives can become available for release into the oralcavity. Some embodiments of the oral product 110 can be adapted toremain non-sticky during and after use. After prolonged use, certainembodiments of the oral product 110 will expand and become flatter. Theoral product, however, can retain the essence of its original shape. Theamount of deformation will depend on the duration of use and an amountof mouth force used. As the product is used, it can increase in bothweight and volume, due to the swelling. With greater the physicalmanipulation, the oral product 110 will have a greater amount ofswelling and thus have a larger weight gain. In certain embodiments, theoral product 110 will have an increase in weight of between 4 and 75percent when chewed by a consumer for 30 minutes.

One way of characterizing the properties of the oral product is bymeasuring the compressibility and springiness of the product. Thecompressibility can be calculated as a percentage of reduction inthickness of the sample when the sample is compressed with astandardized probe with a particular force. As used herein, the term“compression @ 250 N test” defines a test of a sample where the sampleis placed on a flat stationary surface and twice compressed with a 10mm-diameter-sphere-tipped probe with a force of 250 N with a hold timeof 30 seconds between compressions. The “percentage of compression @ 250N” is the maximum amount of reduction in thickness of the sample duringthe compression @250 N test. For example, if a 3 mm thick sample iscompressed to a minimum thickness of 1.5 mm during either of the twocompressions, the sample is said to have a 50% compression @ 250 N. Asused herein, the term “compression @ 425 N test” defines a test of asample where the sample is placed on a flat stationary surface and twicecompressed with a 10 mm-diameter-sphere-tipped probe with a force of 425N with a hold time of 30 seconds between compressions. For comparison, anormal human bite force is typically between 400 and 500 N.

In some embodiments, the oral product 110 has a percentage ofcompression @ 250 N of less than 95%. In certain embodiments, the oralproduct 110 has a percentage of compression @ 250 N of less than 90%,less than 85%, or less than 80%. In certain embodiments, the oralproduct 110 has a percentage of compression @ 250 N of at least 10%, atleast 25%, or at least 40%. For example, the oral product can have apercentage of compression @ 250 N of between 45% and 80%. In someembodiments, the oral product 110 has a percentage of compression @ 425N of less than 99%. In certain embodiments, the oral product 110 has apercentage of compression @ 425 N of less than 98%, less than 97%, orless than 96%. In certain embodiments, the oral product 110 has apercentage of compression @ 425 N of at least 10%, at least 25%, atleast 50%, or at least 60%. For example, the oral product can have apercentage of compression @ 425 N of between 65% and 98%.

The springiness of a sample can be measured by measuring the percentageof recovery after a sample is compressed. As used herein, the term“percentage of springiness” means the percentage of thickness recoveryof the sample during a 30 second recovery time after being compressed bythe compression @ 425 N test using the 10 mm-diameter-sphere-tippedprobe. For example, if a sample is compressed from an original thicknessof 3.0 mm to a thickness of 2.0 mm and then recovers to 2.5 mm after 30seconds, the springiness of the sample would be 50%. In someembodiments, the oral product 110 has a percentage of springiness of atleast 20%. In certain embodiments, the oral product 110 has a percentageof springiness of at least 40%, at least 50%, at least 60%, at least70%, at least 75%, or at least 80%. In certain embodiments, thepercentage of springiness is less than 95%, less than 90%, or less than87%. For example, the oral product can have a percentage of springinessof between 75% and 90%.

The particular materials used in the oral product 110 and the processingtechniques discussed below can have an impact on the compressibility andspringiness of the oral product. In addition to different materials havedifferent compressibility and springiness properties, the incorporationof air bubbles or channels, or different fillers and/or fibers can alsohave an impact on the elasticity and pliability of the oral product.Additionally, the material properties of the overall oral product 110can change as additives are released. In some embodiments, fibers and/orfillers can also dissolve or disintegrate during use and thus alter thematerial properties of the oral product 110 during use.

The oral product 110 can have a variety of colors. In some embodiments,the oral product 110 has an off-white color. In other embodiments,natural and artificial coloring can be added to the mouth-stable polymerbefore or during the molding process to form oral products 110 having apredetermined color. Encapsulated flavors can be added during theextrusion process to create speckles, patterns or dots within the oralproduct.

Polymers

The mouth-stable polymer can be a variety of different biocompatible andbiostable polymers. In some embodiments, the mouth-stable polymer is apolymer generally recognized as safe by an appropriate regulatoryagency. In some embodiments, the polymer is a thermoplastic polymer. Thepolymer can also be a thermoplastic elastomer. For example, suitablemouth-stable polymers include polyurethanes, silicon polymers,polyesters, polyacrylates, polyethylenes, polypropylenes,polyetheramides, polystyrenes (e.g., acrylonitrile butadiene styrene,high impact polystyrenes (HIPS)) polyvinyl alcohols, polyvinyl acetates,polyvinyl chlorides, polybutyl acetates, butyl rubbers (e.g.,polyisobutylenes), SEBS, SBS, SIS, and mixtures and copolymers thereof.In certain embodiments, the mouth-stable polymer is food-grade ormedical-grade polymers (e.g., medical-grade polyurethane).

The mouth-stable polymer forms the mouth-stable polymer matrix of theoral product 110. In some embodiments, the oral product includes atleast 10 weight percent of one or more mouth-stable polymers. In certainembodiments, the oral product includes at least 20 weight percent, atleast 30 weight percent, at least 40 weight percent, at least 50 weightpercent, at least 60 weight percent, at least 70 weight percent, atleast 80 weight percent, or at least 90 weight percent of one or moremouth-stable polymers. In certain embodiments, the oral product includesbetween 10 and 90 weight percent of one or more mouth-stable polymers.Accordingly to some embodiments, the oral product includes between 40and 80 weight percent of the mouth-stable polymers. Some embodiments ofthe oral product have between 55 and 70 weight percent polymers.

The mouth-stable polymer according to certain embodiments has a flexuralmodulus of at least 5 MPa when tested according to ASTM Testing MethodD790 or ISO 178 at 23 degrees Celsius. In some embodiments, the flexuralmodulus is at least 10 MPa. For example, the flexural modulus can bebetween 10 MPa and 30 MPa. In some embodiments, the mouth-stable polymeris a grade that complies with food-contact regulations applicable in oneor more countries (e.g., US FDA regulations). In some embodiments, themouth-stable polymer can be a polyurethane, SIS, or other thermalplastic elastomer meeting the requirements of the FDA-modified ISO10993, Part 1 “Biological Evaluation of Medical Devices” tests withhuman tissue contact time of 30 days or less. The mouth-stable polymercan have a shore Hardness of 50D or softer, a melt flow index of 3 g/10min at 200° C./10 kg, a tensile strength of 10 MPa or more (using ISO37), and a ultimate elongation of less than 100% (using ISO 37).

Additives

A variety of additives can be included in the oral product 110. Theadditives can include alkaloids (e.g., caffeine), minerals, vitamins,dietary supplements, nutraceuticals, energizing agents, soothing agents,coloring agents, amino acids, chemesthetic agent, antioxidants, foodgrade emulsifiers, pH modifiers, botanicals (e.g., green tea), teethwhitening (e.g., SHRIMP), therapeutic agents, sweeteners, flavorants,and combinations thereof. A soothing agent provides a soothing sensationto the throat and oral cavity. Suitable soothing agents include, withoutlimitation, chamomile, lavender, jasmine, and the like. Suitablechemesthetic ingredients provide, without limitation, hot, spicy, orcooling flavors such as mint, menthol, cinnamon, pepper, and the like.

Energizing ingredients or vitamins include, without limitation,caffeine, taurine, guarana, vitamin B6, vitamin B12, and the like.According to certain embodiments, the oral product 110 includescaffeine. A caffeinated oral product can include synthetic caffeineand/or coffee-bean-extracted caffeine. In some embodiments, acaffeinated oral product includes coffee flavors and sweeteners. In someembodiments, the fibers in a caffeinated oral product are coffee beanfibers. According to some embodiments, an oral product can includebetween 10 and 200 mg of caffeine.

Oral products 110 can also include vitamins, dietary minerals, otherdietary supplements, and/or therapeutic agents. For example, suitablevitamins include vitamins A, B1, B2, B6, C, D2, D3, E, F, K, and P. Forexample, an oral product 110 can include C-vitamins with or without thepresence of caffeine. Suitable dietary minerals include calcium (ascarbonate, citrate, etc.) or magnesium (as oxide, etc.), chromium(usually as picolinate), and iron (as bis-glycinate). One or moredietary minerals could be included in an oral product with or withoutthe use of other additives. Other dietary supplements and/or therapeuticagents can also be included as additives.

In some embodiments, the oral product 110 includes a therapeutic agentthat is preferable absorbed transbuccally. For example, so therapeuticagents do not pass into the blood stream if they are swallowed.Exemplary therapeutic agents that can be included in an oral product 110provided herein can include Gerd, Buprenorphin, Nitroglycerin,Diclofenac, Fentanyl, Carbamazepine, Galantamine, Acyclovir,Polyamidoamine Nanoparticles, Chlorpheniramine, Testosterone, Estradiol,Progesterone, Calcitonin, Fluorouracil, Naltrexone, Odansetron,Decitabine, Selegiline, Lamotrigine, and Prochlorperazine. For example,an oral product 110 can include Buprenorphine and be used for paintreatment. In some embodiments, an oral product 110 can includeNitroglycerin and be used for Angina Pectoris treatment. Because of therelease properties of the oral product 110, therapeutic agents includedtherein can be released at a rate such that a majority of thetherapeutic agent is absorbed transbuccally, rather than swallowed.

The oral product 110 can also include fillers such as starch, di-calciumphosphate, lactose, sorbitol, mannitol, and microcrystalline cellulose,calcium carbonate, dicalcium phosphate, calcium sulfate, clays, silica,glass particles, sodium lauryl sulfate (SLS), glyceryl palmitostearate,sodium benzoate, sodium stearyl fumarate, talc, and stearates (e.g., Mgor K), and waxes (e.g., glycerol monostearate, propylene glycolmonostearate, and acetylated monoglycerides), stabilizers (e.g.,ascorbic acid and monosterol citrate, BHT, or BHA), disintegratingagents (e.g., starch, sodium starch glycolate, cross caramellose, crosslinked PVP), pH stabilizers, or preservatives. In some embodiments, theamount of filler in the oral product 110 is limited to less than 10weight percent in sum. In some embodiments, the amount of filler in theoral product 110 is limited to be less than 5 weight percent in sum. Insome embodiments, the fillers are mouth stable. In other embodiments,the fillers can dissolve or disintegrate during use and thus result inan oral product that becomes more pliable during use.

In some embodiments, humectants can be added help maintain the moisturelevels in the oral product 110. Examples of humectants include glycerinand propylene glycol. In some embodiments, anti-microbial agents can beadded to prevent spoilage and to lengthen shelf-life.

Sweeteners

A variety of synthetic and/or natural sweeteners can be used asadditives in the oral product 110. Suitable natural sweeteners includesugars, for example, monosaccharides, disaccharides, and/orpolysaccharide sugars, and/or mixtures of two or more sugars. Accordingto some embodiments, the oral product 110 includes one or more of thefollowing: sucrose or table sugar; honey or a mixture of low molecularweight sugars not including sucrose; glucose or grape sugar or cornsugar or dextrose; molasses; corn sweetener; corn syrup or glucosesyrup; fructose or fruit sugar; lactose or milk sugar; maltose or maltsugar or maltobiose; sorghum syrup; mannitol or manna sugar; sorbitol ord-sorbite or d-sobitol; fruit juice concentrate; and/or mixtures orblends of one or more of these ingredients. The oral product 110 canalso include non-nutritive sweeteners. Suitable non-nutritive sweetenersinclude: stevia, saccharin; Aspartame; sucralose; or acesulfamepotassium.

Flavorants

The oral product 110 can optionally include one or more flavorants. Theflavorants can be natural or artificial. Exemplary flavorants include,but are not limited to, berry flavors such as pomegranate, acai,raspberry, blueberry, strawberry, boysenberry, and/or cranberry. Othersuitable flavorants include, without limitation, any natural orsynthetic flavor or aroma, such as menthol, peppermint, spearmint,wintergreen, bourbon, scotch, whiskey, cognac, hydrangea, lavender,chocolate, licorice, citrus and other fruit flavors, such as apple,peach, pear, kiwi, cherry, plum, orange, lime, grape, lemon, kumquat,and grapefruit, gamma octalactone, vanillin, ethyl vanillin, breathfreshener flavors, butter, rum, coconut, almond, pecan, walnut,hazelnut, French vanilla, macadamia, sugar cane, maple, cassis, caramel,banana, malt, espresso, kahlua, white chocolate, spice flavors such ascinnamon, clove, cilantro, basil, oregano, garlic, mustard, nutmeg,rosemary, thyme, tarragon, dill, sage, anise, and fennel, methylsalicylate, linalool, jasmine, coffee, olive oil, sesame oil, sunfloweroil, bergamot oil, geranium oil, lemon oil, ginger oil, balsamicvinegar, rice wine vinegar, and red wine vinegar. In addition, theflavorants can include cocktail flavors, such as cosmopolitan, martini,margarita, manhattan, pina colada, daiquiri, bellini and the like. Mintoils useful in particular embodiments of the oral product 110 includespearmint and peppermint. Synthetic flavorants can also be used. Theparticular combination of flavorants can be selected from the flavorantsthat are generally recognized as safe (“GRAS”) in a particular country,such as the United States. Flavorants can also be included in the oralproduct as encapsulated flavorants. In some embodiments, the flavorantsin the oral product 110 are limited to less than 20 weight percent insum. In some embodiments, the flavorants in the oral product 110 arelimited to be less than 10 weight percent in sum. For example, certainflavorants can be included in the oral product 110 in amounts of about 1weight percent to 5 weight percent.

Fibers

The oral product can include fibers within the mouth-stable polymermatrix. FIG. 4 depicts an illustration of how a plurality of fibers 130can be dispersed in a mouth-stable polymer matrix 120. As will bediscussed below, the fibers can be mixed with the mouth-stable polymerprior to or during an extrusion process. As shown in FIG. 4, the fibersprovide passages in the mouth-stable polymer matrix, which can permitcertain additives within the mouth-stable polymer matrix to be releasedinto an oral cavity when the oral product is received in an oral cavityand exposed to saliva. The additives can be absorbed in the mouth-stablepolymer matrix and/or form pockets within the mouth-stable polymermatrix, which can be accessed via the fibers 130. The oral product 110can also include channels 135 formed adjacent the fibers 130. In someembodiments, the fibers are hydrophilic such that water-solubleadditives can be wicked by the fibers. In some embodiments, the fiberscan dissolve to leave channels. Additives 140 can be present in themouth-stable polymer matrix 120.

The fibers can be cellulosic fibers. The cellulosic fibers can bederived from plant tissue. In some embodiments, the cellulosic fibersincludes cellulose. The cellulosic fibers can further include ligninand/or lipids. Suitable sources for cellulosic fibers include wood pulp,cotton, sugar beets, bran, citrus pulp fiber, switch grass and othergrasses, Salix (willow), tea, and Populus (poplar). In some embodiments,the cellulosic fibers can be plant tissue comprising various naturalflavors, sweeteners, or active ingredients. For example, coffee beanscan be ground into fibers and incorporated into the mouth-stable polymermatrix to provide a fibrous structure, flavor, and caffeine.

The cellulosic fibers can have a variety of dimensions. The dimensionsof the fibers (in addition to the amount) can impact the releasecharacteristics of the additives. For example, cellulosic fibers can behydrophilic, thus water soluble additives (e.g., caffeine) canpreferentially be absorbed in the fiber-polymer matrix. The releaseprofile of the additive from a polyurethane oral product 110 can beimpacted by both the fiber sizes and the amounts of fiber. In certainembodiments, the cellulosic fiber can be processed to have an averagefiber size of less than 200 micrometers. In particular embodiments, thefibers are between 75 and 125 micrometers. In other embodiments, thefibers are processed to have a size of 75 micrometers or less.

The oral product 110 can also include soluble fibers. The soluble fiberscan be adapted to dissolve when exposed to saliva when the oral product110 is received in an oral cavity. Soluble fibers can be used alone orwith cellulosic fibers to provide channels 135 for additives 140 and/or142 to be released from the oral product 110. As the soluble fibersdissolve, the oral product 110 can become more flexible and theadditional channels can open up to permit the release of additionaladditive deposits 140 or 142. Suitable soluble fibers include psylliumfibers. In other embodiments, the fibers can be partially soluble. Forexample, sugar beet fibers can partially dissolve during use.

In some embodiments, an oral product 110 can include a combination ofsoluble and insoluble fibers. The ratio of soluble to insoluble fibercan impact the softness of texture of the oral product 110. The ratio ofsoluble to insoluble fiber can also impact the compressibility of theoral product 110. In some embodiments, a ratio of soluble to insolublefiber is between 1:60 and 60:1. In some embodiments, the ratio ofsoluble to insoluble fiber is greater than 1:50, greater than 1:40,greater than 1:30, greater than 1:20, greater than 1:10, or greater than1:5. In some embodiments, the ratio of soluble to insoluble fiber isless than 1:1, less than 1:2, less than 1:5, less than 1:10, less than1:20, or less that 1:30. In some case, an oral product having a mixtureof soluble and insoluble fibers can have a percentage of compression @250 N of between 60 percent and 98 percent, between 65 percent and 95percent, between 70 percent and 90 percent, or between 80 and 89percent.

The inclusion of soluble fiber can increase the compressibility of theoral product, which can also be perceived as a softer mouth feel by aconsumer. The soluble and the insoluble fiber can be pre-mixed and addedinto the process via a single feeder. Separate fiber feeders can also beused to produce a desired ratio. In some cases, the inclusion of about1-3% of soluble fiber and about 25-35% insoluble fiber can result in aCompression @250N of between 70% and 90%.

Plasticizers

The oral product 110 can also include one or more plasticizers.Plasticizers can soften the final oral product and thus increase itsflexibility. Plasticizers work by embedding themselves between thechains of polymers, spacing them apart (increasing the “free volume”),and thus significantly lowering the glass transition temperature for theplastic and making it softer. Suitable plasticizers include propyleneglycol, glycerin, vegetable oil, and medium chain triglycerides. In someembodiments, the plasticizer can include phthalates. Esters ofpolycarboxylic acids with linear or branched aliphatic alcohols ofmoderate chain length can also be used as plasticizers. Moreover,plasticizers can facilitate the extrusion processes described below. Insome embodiments, the oral product 110 can include up to 20 weightpercent plasticizer. In some embodiments, the oral product 110 includesbetween 0.5 and 10 weight percent plasticizer, the oral product 110 caninclude between 1 and 8 weight percent plasticizer, or between 2 and 4weight percent plasticizer. For example, an oral product comprising apolyurethane polymer matrix and include about 3 to 6.5 weight percent ofpropylene glycol.

Molding Processes

The oral product 110 can be produced by extruding a mouth-stable polymer(e.g., polyurethane) with fibers (e.g., cellulosic fiber) and/oradditive (e.g., caffeine) to form a rod of a mouth-stable polymer matrixincluding fibers and/or additives. The rod is cut into individual oralproducts 110. FIGS. 5A and 5B depict exemplary methods to form oralproducts 110.

Referring to the extrusion process illustrated in FIG. 5A, amouth-stable polymer 510 (e.g., polyurethane) is introduced into anextruder for extrusion 520 along with fibers 512 (e.g., cellulosicfibers). The fibers 512 can be passed through a sieve 514 prior tointroduction into the extruder. A mixture of additives 516 can also beintroduced into the extruder. The mixture of additives 516 can be asolution (as shown). As shown, the additives can include a plasticizer517 (e.g., propylene glycol) and a sweetener 518 (e.g., sucralose). Themixture of additives can also be provided in slurry form or a dry mix ofpowdered additives.

FIG. 5B illustrates an example of how the mouth-stable polymer 510(e.g., polyurethane) can be compounded with fiber 512 and a mixture ofadditives 516. As shown, polyurethane pellets 510 and cellulosic fibers512 can be introduced into an infeed section of an extruder. A firstsection of the extruder melts and mixes the polymer, elevating thetemperature to about 150° C. The mixture 516 of propylene glycol 517 andsucralose 518 can be injected into the extruder downstream of the infeedsection of the extruder. The polymer/fiber/plasticizer/sweetener mixturecan then be extruded out of an extrusion die 720 at a temperature ofabout 150° C. An example of an extrusion die is shown in FIG. 7. Forexample, the extruder of FIG. 5B can operate at a mass flow rate ofabout 1.8 lbs/hour.

The polymer-fiber combination can exit an extrusion die 720 as a rod 710and onto a moving conveyor 730, as shown in FIG. 7. The size of theextrusion die 720, the take away speed of the moving conveyor 730, themixture of polymer-fiber combination, and the temperature of the mixtureexiting the die 720 can all have an impact on the final diameter of therod 710.

The extruded polymer-fiber rod 710 is then cut in a cutting process 530,as shown in FIG. 5A. The cutting can be hot-face cutting. Hot-facecutting can occur immediately after the rod 720 exits the extrusion die720. The cutting can induce pillowing of the polymer matrix, as shown inFIG. 8. The cutting process 530 can also include a process of roundingthe edges of the cut polymer-fiber composite. For example, a pelletizercan be used to round the edges. The pelletizer can also help to cool theoral products 110. In other embodiments, the extruded polymer-fiber rod710 is cooled prior to cutting.

Before or after cutting, additional additives and/or flavorants can beadded to the extruded polymer-fiber rod and/or pieces. As shown in FIG.5A, a mixture of additives 550 and a mixture of flavorants 560 can beabsorbed into polymer-fiber pieces in one or more absorbing processes540. The mixture of additives 550 can include active 552 (e.g.,caffeine) and water 554. A mixture of flavorants 560 can include aflavor 562 (e.g., wintergreen) and a carrier 564 (e.g., ethanol). Theoral products 110 could then be dried, packaged, and sealed.

FIG. 6A depicts an alternative arrangement where a mouth-stable polymer510 (e.g., polyurethane) is compounded with a mixture 516 of one or moreplasticizers 517 (e.g., propylene glycol) and/or sweeteners 518 (e.g.,sucralose) in a first extrusion process 622. The compoundedpolymer/plasticizer/sweetener mixture is then compounded with fiber 512in a second extrusion process 624. As shown, additives such as active552 (e.g., caffeine) and/or flavorants 562 can also be added during thesecond extrusion process 624. In some embodiments, the compounding inthe first extrusion process occurs at a higher temperature than thecompounding during the second extrusion process. Both extrusionprocesses can occur in a single extruder.

FIG. 6B depicts an arrangement of an extruder where the active,plasticizer, fibers and flavorants are all added the mouth-stablepolymer in the extruder. Polyurethane pellets 510 are added to an infeedsection 610 of the extruder 620. Plasticizer 517 (e.g., propyleneglycol) (and optionally actives, sweeteners, and/or carriers) areinjected into a first section of the extruder and compounded with thepolyurethane. A vent 640 can be provided to release volatiles.Cellulosic fibers 512 can be introduced into the extruder through a sidefeeder 630. A flavorant mixture 560 can be added through liquid injector660 in a flavor mixing section of the extruder. Active 52 (e.g.,caffeine) and plasticizer 517 can also be injected through liquidinjector 660. The mixture can then be extruded through an extrusion die720 at a temperature of about 165° C. The extruded mixture can behot-cut as it exits the extrusion die 720 and passed to a pelletizer. Inother embodiments, the extruded mixture can be cooled on a coolingconveyer and cut. For example, the extruder of FIG. 6B can operate at amass flow rate of about 5.5 lbs/hour. After cutting, the oral products110 can be further flavored in a pan coater. The oral products 110 canthen be sent to bulk storage and packaged.

In addition to the methods described above, there are many methods formaking and shaping the oral products. In some embodiments, extruded andcut pieces can be introduced into a compression mold to form a finaloral product shape. In other embodiments, the oral product 110 can beinjection molded, compression molded, or injection-compression molded.Blocks of polymer, fiber, and/or additive can also be formed andmachined into a desired shape.

OTHER EMBODIMENTS

It is to be understood that, while the invention has been describedherein in conjunction with a number of different aspects, the foregoingdescription of the various aspects is intended to illustrate and notlimit the scope of the invention, which is defined by the scope of theappended claims. Other aspects, advantages, and modifications are withinthe scope of the following claims.

Disclosed are methods and compositions that can be used for, can be usedin conjunction with, can be used in preparation for, or are products ofthe disclosed methods and compositions. These and other materials aredisclosed herein, and it is understood that combinations, subsets,interactions, groups, etc. of these methods and compositions aredisclosed. That is, while specific reference to each various individualand collective combinations and permutations of these compositions andmethods may not be explicitly disclosed, each is specificallycontemplated and described herein. For example, if a particularcomposition of matter or a particular method is disclosed and discussedand a number of compositions or methods are discussed, each and everycombination and permutation of the compositions and the methods arespecifically contemplated unless specifically indicated to the contrary.Likewise, any subset or combination of these is also specificallycontemplated and disclosed.

What is claimed is:
 1. A method of forming an oral product comprising:extruding a mouth-stable polymer having cellulosic fibers dispersedtherein to form a porous fiber-polymer matrix, the mouth-stable polymerincluding polyurethane; dispersing an additive within the mouth-stablepolymer during or after the extruding, the additive including aflavorant, a sweetener, caffeine, or any combination thereof, theadditive being disposed within pores of the porous fiber-polymer matrix,the cellulosic fibers providing passages to the pores and beingconfigured to release the additive when the porous fiber-polymer matrixis exposed to saliva; and creating individual oral products from theporous fiber-polymer matrix, the individual oral products being sized tobe at least partially received in an oral cavity, the oral productshaving a compressibility @ 250 N ranging from 45% to 90% and aspringiness ranging from 75% to 95%, wherein a first portion of thepores have a first diameter ranging from 40 microns to 60 microns and asecond portion of the pores have a second diameter ranging from 1 micronto 10 microns.
 2. The method of claim 1, wherein the creating includescutting the porous fiber-polymer matrix into the individual oralproducts.
 3. The method of claim 1, wherein the dispersing is performedduring the extruding.
 4. The method of claim 1, wherein the dispersingis performed after the extruding.
 5. The method of claim 1, furthercomprising: dispersing a plasticizer in the mouth-stable polymer.
 6. Themethod of claim 1, wherein the individual oral products are configuredto be pliable when manipulated within the oral cavity.
 7. The method ofclaim 1, wherein the creating includes forming the porous fiber-polymermatrix into the individual oral products.
 8. The method of claim 1,wherein the polyurethane is present in an amount greater than or equalto 60 weight percent.
 9. The method of claim 5, wherein the dispersingthe plasticizer is performed during the extruding.
 10. The method ofclaim 9, wherein the plasticizer includes propylene glycol, glycerin,vegetable oil, a triglyceride, or any combination thereof.
 11. Themethod of claim 1, wherein the additive includes the sweetener.
 12. Themethod of claim 11, wherein the sweetener includes saccharine,sucralose, aspartame, acesulfame potassium, or any combination thereof.13. The method of claim 1, wherein the additive includes the flavorant.14. The method of claim 13, wherein the flavorant includes licorice,wintergreen, cherry and berry type flavorants, bourbon, scotch, whiskey,spearmint, peppermint, lavender, cinnamon, cardamon, Apium graveolens,clove, cascarilla, nutmeg, sandalwood, bergamot, geranium, honeyessence, rose oil, vanilla, lemon oil, orange oil, Japanese mint,cassia, caraway, cognac, jasmine, chamomile, menthol, ylang-ylang, sage,fennel, pimenta, ginger, anise, coriander, coffee, mint oils from aspecies of the genus Mentha, or any combination thereof.
 15. The methodof claim 1, wherein the additive further includes a mineral, a vitamin,a dietary supplement, a nutraceutical, an energizing agent, a soothingagent, an amino acid, a chemesthetic agent, an antioxidant, a botanical,a teeth whitening agent, a therapeutic agent, or any combinationthereof.
 16. The method of claim 1, wherein the additive furtherincludes a therapeutic agent including Gerd, Buprenorphin,Nitroglycerin, Diclofenac, Fentanyl, Carbamazepine, Galantamine,Acyclovir, Polyamidoamine Nanoparticles, Chlorpheniramine, Testosterone,Estradiol, Progesterone, Calcitonin, Fluorouracil, Naltrexone,Odansetron, Decitabine, Selegiline, Lamotrigine, Prochlorperazine, orany combination thereof.
 17. The method of claim 1, wherein theindividual oral products are shield-shaped.
 18. The method of claim 1,wherein the individual oral products each have a diameter ranging from 5mm to 25 mm.
 19. The method of claim 1, wherein the cellulosic fibershave an average fiber size of less than 200 microns.
 20. The method ofclaim 1, wherein the individual oral products each have a thicknessranging from 1 mm to 10 mm.
 21. The method of claim 2, wherein theindividual oral products have shape memory.
 22. The method of claim 1,wherein the polyurethane is present in an amount ranging from 40 weightpercent to 80 weight percent.